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Intra-operatieve fluorescente beeldvorming van neuroendocriene tumoren.


- candidate number14019
- NTR NumberNTR3714
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2012
- Secondary IDsP10.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van neuroendocriene tumoren.
- Scientific TitleIntra-operative fluorescent imaging of neuroendocrine tumors.
- ACRONYMGREEN LIGHT
- hypothesisNear-infrared fluorescent imaging can accurately detect neuroendocrine tumors non-invasively during surgical procedures.
- Healt Condition(s) or Problem(s) studiedNeuroendocrine tumors
- Inclusion criteria1. Patients diagnosed with neuroendocrine tumors eligible to undergo a curative resection;
2. Age between 18 and 80 years old.
- Exclusion criteria1. Patients using SSRI's, SNRI's of TCA's;
2. Allergy to methyleen blue, history of severe renal impairment or G6PD-deficiency;
3. Patient pregnant or lactating.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-jun-2014
- Target number of participants20
- InterventionsStandard surgical procedure will be performed. During surgery, the near-infrared dye Methylene blue (MB) will be injected and the neuroendocrine tumor will be visualized non-invasively using our experimental camerasystem.
- Primary outcomePrimary outcome parameter is the number of identified neuroendocrine tumors.
- Secondary outcomeSecundary parameters are the tumor-to-background ratios measured in patients that recieved MB.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryIntraoperative identification of neuroendocrine tumors can be very challeging. Complete resection of the tumor is essential for curation. To reduce the number of patients with positive resection margins, near-infrared fluorescence imaging can be very usefull.

The aim of this study is test feasibility for intraoperative detection of neuroendocrine tumors using methylene blue and NIR fluorescence.
- Main changes (audit trail)
- RECORD21-nov-2012 - 1-dec-2012


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